Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions.

PURPOSE: To evaluate the safety and efficacy of a self-expanding bare-metal nitinol stent (Astron; BIOTRONIK AG, Bülach, Switzerland) for the treatment of atherosclerotic lesions in the common and external iliac arteries. This study tested the hypothesis that the major adverse event (MAE) rate at 12 months was less than or equal to a performance goal of 15%. MATERIALS AND METHODS: In a prospective study that began in November 2011, 161 patients with symptomatic iliac lesions were treated with an Astron stent in the United States, Canada, and Austria. The primary endpoint was a composite rate of procedure- and stent-related MAEs at 12 months that included 30-day mortality, clinically indicated target lesion revascularization (TLR), and index limb amputation. RESULTS: The MAE rate at 12 months was 2.1% (3/146; [95% CI: 0.4% to 5.9%]; p < 0.001). The acute procedural success and 30-day clinical success outcomes were both 95% (153/161). The primary patency rate at 12 months was 89.8% (115/128). The comparison of baseline and 12-month Ankle Brachial Index (ABI) measurements showed a mean increase of 0.23 ± 0.19 (p < 0.001). The Walking Impairment Questionnaire (WIQ) PAD specific score, walking distance score, walking speed score and stair climbing score paired each showed a significant increase from baseline to 12 months (p<0.001). CONCLUSIONS: The Astron stent system was shown to be safe and effective in the treatment of patients with atherosclerotic disease. The observed MAE rate met the pre-specified performance goal of 15%. The stent demonstrated a high 12-month primary patency rate and showed improvement in quality of life measures.

Comparison of Clinical Outcomes following Glue versus Polyvinyl Alcohol Portal Vein Embolization for Hypertrophy of the Future Liver Remnant prior to Right Hepatectomy.

PURPOSE: To report outcomes after portal vein embolization (PVE) and right hepatectomy in patients receiving embolization with N-butyl cyanoacrylate (NBCA) glue + central AMPLATZER Vascular Plug (AVP; glue group) or polyvinyl alcohol (PVA) particles ± coils (PVA group). MATERIALS AND METHODS: Between March 2008 and August 2013, all patients having PVE with NBCA + AVP or PVA ± coils before right hepatectomy were retrospectively reviewed; 85 patients underwent PVE with NBCA + AVP (n = 45) or PVA ± coils (n = 40). The groups were compared using Mann-Whitney U and χ2 tests. RESULTS: Technical success of embolization was 100%. Degree of hypertrophy (16.2% ± 7.8 vs 12.3% ± 7.62, P = .009) and kinetic growth rate (3.5%/wk ± 2.0 vs 2.6%/wk ± 1.9, P = .016) were greater in the glue group versus the PVA group. Contrast volume (66.1 mL ± 44.8 vs 189.87 mL ± 62.6, P < .001) and fluoroscopy time (11.2 min ± 7.8 vs 23.49 min ± 11.7, P < .001) were significantly less during the PVE procedure in the glue group. Surgical outcomes were comparable between groups, including the number of patients unable to go onto surgery (P = 1.0), surgical complications (P = .30), length of hospital stay (P = .68), and intensive care unit admissions (P = .71). There was 1 major complication (hepatic abscess) in each group after PVE. CONCLUSIONS: PVE performed with NBCA + AVP compared with PVA ± coils resulted in greater degree of hypertrophy of the future liver remnant, less fluoroscopic time and contrast volume, and similar complication rates.

Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair.

PURPOSE: To evaluate the feasibility and safety of a novel balloon-expandable, heparin-bonded endoprosthesis (Viabahn VBX, W. L. Gore and Associates) when used as a bridging stent graft (BSG) with fenestrated and branched endovascular aneurysm repair (FB-EVAR). FB-EVAR and BSGs increase repair complexity with the potential for endoleak formation, stenosis, thrombosis, and graft migration. The mechanical construction of the Viabahn VBX and its antithrombogenic properties may provide an advantage for FB-EVAR over existing BSGs. The efficacy, safety, and clinical outcomes were assessed. MATERIALS AND METHODS: Research ethics board approved, prospective, single arm cohort, pilot study of patients undergoing FB-EVAR between February 2017 and January 2018. Fenestrated and branched endovascular aneurysm repair was performed per the standard institutional protocol by a team composed of vascular surgeons and interventional radiologists. Viabahn VBX endografts were used for all intended visceral branches as long as appropriately sized devices were available (Under Investigational Testing Authorization from Health Canada). Patient characteristics, procedural details, and technical and clinical outcomes were reviewed and summarized. RESULTS: FB-EVAR was performed in 13 patients (9 male and 4 female) mean age of 74 (range: 61-83) with a total of 41 Viabahn VBXs stents implanted. Mean maximum aneurysm size was 6.7 cm (range: 5.5-9.0 cm) and included 5 juxtarenal abdominal aortic aneurysms and 8 thoracoabdominal; 3 type V, 3 type IV, and 2 type III (Crawford Classification). The Viabahn VBX was successfully deployed in 40 (98%) of 41 of cases. At median follow-up of 223 days (range: 2-462), there was a (40/40) 100% Viabahn VBX patency rate. Seven endoleaks were identified intra- or post procedurally in 6 (46%) of 13 cases, including 1 type IB, 3 type II, 2 type III, and 1 unclassified. Nine complications occurred in 6 patients. CONCLUSION: The Viabahn VBX stent is a safe and effective BSG for FB-EVAR with no early stent thrombosis. Further evaluation is required to determine longer term stent efficacy.